Nasal PolyposisPhase 3NCT01906697
The Effect of RF Turbinoplasty in Polypoid Change of Middle Turbinates
A Phase 3 study testing middle turbinate Radio Frequency (RF) turbinoplasty, middle turbinate resection and middle turbinate medialization in people with Nasal Polyposis and Sinusitis, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of this study is to evaluate the effect of middle turbinate Radio Frequency (RF) turbinoplasty with middle turbinate resection and medialization Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasal Polyposis, Sinusitis
- What is being tested?
- middle turbinate Radio Frequency (RF) turbinoplasty, middle turbinate resection and middle turbinate medialization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIran
- Study dates
- May 2011to Oct 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients with sinusitis who suffered from nasal polyposis which was resistant to maximal medical treatment (i.e. one puff of Fluticasone nasal spray twice daily plus amoxicillin clavulanic acid 625 mg tablet three times daily, for at least one month ).
Who cannot join
- floppy' change of the middle turbinate in the end of surgery.
- systemic disease (e.g. hypertension, Wegener's granulomatosis, cystic fibrosis or sarcoidosis),
- immune suppression,
- revision surgery,
- counter-indications for any of the postoperative drug usage (e.g. diabetes or pregnancy), or
- any type of septoplasty indications are excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of RF Turbinoplasty Versus Two Other Methods in Management of Polypoid Change of Middle Turbinates: A Randomized Trial.
The aim of this study is to evaluate the effect of middle turbinate Radio Frequency (RF) turbinoplasty with middle turbinate resection and medialization
Read the detailed description
The management of middle turbinate in treatment of nasal polyposis is still an interesting debatable topic. The surgical access and its possible role in pathophysiology of sinusitis are two important points about its treatment. On the one hand, middle turbinate resection can improve surgical access and possibly reduce the nasal polyposis recurrence. On the other hand, there are some reports of anosmia, empty nose syndrome, synechia, and difficulties in revision surgery. Also, synechia, lateralization, and possibly recurrence can be the possible outcome after middle turbinate preservation.
Among different modalities, radiofrequency (RF) gradually increase its popularity as surgical tools, which can treat mucosal hypertrophy without any tissue removal. Inferior turbinate is a famous place for its usage, especially for decreasing of the nasal obstruction. Also, some authors have showed its effect on refractory allergic rhinitis, which is not only related to reducing of nasal obstruction, but also it is related to changing of the allergic mediators. [5, 6] Comparing to other treatments for turbinates is sparing its overlaid mucosa, which can reduce the possible future morbidities.
Probably considering of the above mention points, RF has a possible impact on the polypoid changes of middle turbinates and possibly does not have the same deleterious effect of the resection on cilia of mucosal layer. Therefore, we performed a randomized clinical trial to compare its outcome with two famous methods of the middle turbinate management: partial resection and medialization.
- Conditions
- Nasal Polyposis, Sinusitis
- Being tested
- middle turbinate Radio Frequency (RF) turbinoplasty, middle turbinate resection, middle turbinate medialization
- Medical subject headings
- Nasal Polyps, Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
middle turbinate Radio Frequency (RF) turbinoplastyProcedure or surgery
middle turbinate Radio Frequency (RF) turbinoplasty
middle turbinate resectionProcedure or surgery
middle turbinate resection
middle turbinate medializationProcedure or surgery
middle turbinate medialization
| Study group | Role | What they receive |
|---|---|---|
| group B | Active comparator | middle turbinate resection Receives: Procedure: middle turbinate resection |
| group C | Active comparator | middle turbinate medialization Receives: Procedure: middle turbinate medialization |
| group A | Active comparator | middle turbinate Radio Frequency (RF) turbinoplasty Receives: Procedure: middle turbinate Radio Frequency (RF) turbinoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Sino-Nasal Outcomes Test 22
The Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire is a disease-specific questionnaire involving 22 symptoms combining rhinologic issues with general health issues.
Measured: three months after surgery
The Sino-Nasal Outcomes Test 22
The Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire is a disease-specific questionnaire involving 22 symptoms combining rhinologic issues with general health issues.
Measured: 6 months after surgery
The Sino-Nasal Outcomes Test 22
The Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire is a disease-specific questionnaire involving 22 symptoms combining rhinologic issues with general health issues.
Measured: one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startMay 2011
- Primary completionSep 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal PolyposisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Babak Saedi, Tehran University of Medical Sciences
- Investigators
- Babak Saedi, professor, Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906697
- Sponsor's protocol ID
- 92--02-48-6933
- Status last verified
- Jul 2013
- First submitted
- 19 Jul 2013
- Last updated
- 24 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of RF Turbinoplasty Versus Two Other Methods in Management of Polypoid Change of Middle Turbinates: A Randomized Trial.
- ClinicalTrials.gov ID
- NCT01906697
- Acronym / sponsor ID
- 92--02-48-6933
- Conditions
- Nasal Polyposis, Sinusitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 24 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the effect of middle turbinate Radio Frequency (RF) turbinoplasty with middle turbinate resection and medialization
Detailed description
The management of middle turbinate in treatment of nasal polyposis is still an interesting debatable topic. The surgical access and its possible role in pathophysiology of sinusitis are two important points about its treatment. On the one hand, middle turbinate resection can improve surgical access and possibly reduce the nasal polyposis recurrence. On the other hand, there are some reports of anosmia, empty nose syndrome, synechia, and difficulties in revision surgery. Also, synechia, lateralization, and possibly recurrence can be the possible outcome after middle turbinate preservation.
Among different modalities, radiofrequency (RF) gradually increase its popularity as surgical tools, which can treat mucosal hypertrophy without any tissue removal. Inferior turbinate is a famous place for its usage, especially for decreasing of the nasal obstruction. Also, some authors have showed its effect on refractory allergic rhinitis, which is not only related to reducing of nasal obstruction, but also it is related to changing of the allergic mediators. [5, 6] Comparing to other treatments for turbinates is sparing its overlaid mucosa, which can reduce the possible future morbidities.
Probably considering of the above mention points, RF has a possible impact on the polypoid changes of middle turbinates and possibly does not have the same deleterious effect of the resection on cilia of mucosal layer. Therefore, we performed a randomized clinical trial to compare its outcome with two famous methods of the middle turbinate management: partial resection and medialization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group B | Active comparator | Procedure: middle turbinate resectionmiddle turbinate resection |
| group C | Active comparator | Procedure: middle turbinate medializationmiddle turbinate medialization |
| group A | Active comparator | Procedure: middle turbinate Radio Frequency (RF) turbinoplastymiddle turbinate Radio Frequency (RF) turbinoplasty |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients with sinusitis who suffered from nasal polyposis which was resistant to maximal medical treatment (i.e. one puff of Fluticasone nasal spray twice daily plus amoxicillin clavulanic acid 625 mg tablet three times daily, for at least one month ).
Key exclusion criteria (6 listed)
- floppy' change of the middle turbinate in the end of surgery.
- systemic disease (e.g. hypertension, Wegener's granulomatosis, cystic fibrosis or sarcoidosis),
- immune suppression,
- revision surgery,
- counter-indications for any of the postoperative drug usage (e.g. diabetes or pregnancy), or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| middle turbinate Radio Frequency (RF) turbinoplastymiddle turbinate Radio Frequency (RF) turbinoplasty | Procedure or surgery | group A |
| middle turbinate resectionmiddle turbinate resection | Procedure or surgery | group B |
| middle turbinate medializationmiddle turbinate medialization | Procedure or surgery | group C |
Primary outcome
The Sino-Nasal Outcomes Test 22
Time frame: three months after surgery
The Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire is a disease-specific questionnaire involving 22 symptoms combining rhinologic issues with general health issues.
The Sino-Nasal Outcomes Test 22
Time frame: 6 months after surgery
The Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire is a disease-specific questionnaire involving 22 symptoms combining rhinologic issues with general health issues.
The Sino-Nasal Outcomes Test 22
Time frame: one year after surgery
The Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire is a disease-specific questionnaire involving 22 symptoms combining rhinologic issues with general health issues.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Babak Saedi, professor principal investigator
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing middle turbinate Radio Frequency (RF) turbinoplasty, middle turbinate resection and middle turbinate medialization in people with Nasal Polyposis and Sinusitis, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Sino-Nasal Outcomes Test 22 (time frame: three months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2013.